Dr Richard J. Willke on the Value of Real-World Data for Health Plans

According to Richard J. Willke, PhD, chief science officer of ISPOR, real-world data has some unique advantages over randomized clinical trial findings, especially for health plans looking to make coverage decisions.

Transcript (slightly modified)

In what ways can real-world data provide better information for decision making than classical clinical trials?

I would say real-world data should be viewed as complimentary to randomized clinical trial, or RCT, data. RCT data are still the gold standard for determining treatment safety and efficacy of course, but we also know that they’re typically performed in restricted settings and restricted populations, which probably aren’t like the health plan characteristics. So the health plans want to track how the treatment really does in its own population.

One of the first things it looks at is often at adherence, because it’s easy to measure, and then analyze the association with outcomes and probably medical costs. It can also look treatments of populations, 1 treatment versus other comparators, things that were never studied in randomized clinical trials. Now, this has to be done carefully, because the real-world data weren’t randomized, so good methodology is really important. But if it’s done carefully, it can aid health plans in decision making about utilization management, step audits, co-pays, prior authorization: the kind of things that help the health plan optimize one treatment as it fits with other treatments.